MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) LASSO 2515 NAV VARIABLE CATHETER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-1290-02-S

Device Problems Signal Artifact/Noise (1036); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2013

Event Type  malfunction  

Event Description

During a procedure, it was reported that an error 8 occurred while the lamp of the ecg card at the patient interface unite (piu) back was blinking in red and green alternately.Noise occurred at all electrical potentials of the lasso® 2515 nav variable catheter both on carto 3 and lab.The cables connected to the 20 pole a and b, were exchanged for new ones and piu was rebooted, but the issue continued.The issue was resolved after the catheter connected to the 20 pole a was exchanged for a new one.The procedure was completed successfully without any patient consequences.On (b)(4), received additional information requested from bwi representative stating that the noise occurred on all channels, including the 12 leads of body surface and all intracardiac recordings, on both carto and recording system at the same time.Due to this additional information received, this complaint became reportable.Awareness date changed from (b)(6) 2013 to (b)(6) 2014.

Manufacturer Narrative

The device has been disposed by the customer.(b)(4).

Manufacturer Narrative

Since the lot # 15828707 was provided, the device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

• Brand Name: LASSO 2515 NAV VARIABLE CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3674430
• MDR Text Key: 4299886
• Report Number: 2029046-2014-00073
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1290-02-S
• Device Catalogue Number: LN122515CT
• Device Lot Number: UNKNOWN_D-1290-02-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2013
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1